APTOS AN2GSL

GUDID 04860120240351

Surgical Sutures, Non-Absorbable, Polypropylene

Aptos, LLC

Polyolefin suture, monofilament

• Primary Device ID: 04860120240351
• NIH Device Record Key: dbd1afd1-7eed-4c22-b4f5-2eee7df7fa8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APTOS
• Version Model Number: Aptos Needle 2G Soft Large
• Catalog Number: AN2GSL
• Company DUNS: 360531712
• Company Name: Aptos, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge
• Phone: +995322920372
• Email: tamara.beshidze@aptos.ge

Device Dimensions

• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter
• Length: 500 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04860120240351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192953

FDA Product Code

• GAW: Suture, nonabsorbable, synthetic, polypropylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [APTOS]

• 04860120240351: Surgical Sutures, Non-Absorbable, Polypropylene
• 04860120240344: Surgical Sutures, Non-Absorbable, Polypropylene